諾和諾德 (Novo Nordisk) 報告稱,在 GLP-1 治療的推動下,2024 年前 9 個月的銷售和營業利潤強勁增長。該公司強調了對永續發展和擴大患者覆蓋範圍的承諾。他們在北美和國際上看到了顯著的銷售成長,特別是在糖尿病市場。
諾和諾德正在投資提高供應能力,並等待法律問題的裁決。該公司預計 Catalent 交易將於今年底完成,預計 2025 年銷售額將持續成長。
討論了公司 2025 年的策略願景,預計將在 2025 年底或 2026 年初發布新的中期指引。
使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good day and thank you for standing by. Welcome to the third-quarter 2024 Novo Nordisk AS earnings conference call. (Operator Instructions)
美好的一天,感謝您的支持。歡迎參加諾和諾德 2024 年第三季財報電話會議。 (操作員說明)
Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Jacob Rode, Head of Investor Relations. Please go ahead.
請注意,今天的會議正在錄製中。現在我想將會議交給今天的第一位發言人,投資者關係主管雅各布·羅德 (Jacob Rode)。請繼續。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you. Welcome to this Novo Nordisk earnings call for the first nine months of 2024. My name is Jacob Martin Rode, and I'm the Head of Investor Relations at Novo Nordisk.
謝謝。歡迎參加諾和諾德 2024 年前 9 個月的財報電話會議。
With me today, I have CEO of Novo Nordisk, Lars Jorgensen; Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvest; Executive Vice President and Head of North America Operations, Doug Langa; Executive Vice President and Head of Development, Martin Holst Lange; and finally, Chief Financial Officer, Karsten Knudsen. All speakers will be available for the Q&A session.
今天和我在一起的有諾和諾德首席執行官拉爾斯·喬根森 (Lars Jorgensen);執行副總裁兼商業策略與企業事務主管 Camilla Sylvest;執行副總裁兼北美營運主管 Doug Langa;執行副總裁兼開發主管 Martin Holst Lange;最後是財務長 Karsten Knudsen。所有演講者都將參加問答環節。
Today's announcement and the slides for this call are available on our website, novonordisk.com. Please note that the call is being webcasted live, and a recording will be made available on our website as well. The call is scheduled to last one hour. Please turn to the next slide.
今天的公告和本次電話會議的幻燈片可在我們的網站 novonordisk.com 上取得。請注意,此通話正在進行網路直播,錄音也將在我們的網站上提供。通話預計可持續一小時。請翻到下一張投影片。
The presentation is structured as outlined on slide 2. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.
此簡報的結構如投影片 2 所示。
Next slide, please. We need to advise you that this call will contain forward-looking statements. These are subject to risks and uncertainties that could cause actual results to differ materially from expectations.
請下一張投影片。我們需要告知您,本次電話會議將包含前瞻性陳述。這些都存在風險和不確定性,可能導致實際結果與預期有重大差異。
For further information on the risk factors, please see the company announcement for the first nine months of 2024 and the slides prepared for this presentation.
有關風險因素的更多信息,請參閱 2024 年前 9 個月的公司公告以及為本次演示準備的幻燈片。
With that, over to you, Lars, for an update on our strategic aspirations.
現在,拉斯,請您了解我們策略願景的最新情況。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Thank you, Jacob. Next, please. In the first nine months, we delivered 24% sales growth and 22% operating profit growth. This reflects continued scaling of the company, and we now reach around three times more patients with our GLP-1 treatments compared to three years ago. Increased visibility on the full year performance has led us to narrow our guidance range.
謝謝你,雅各。接下來請。前 9 個月,我們的銷售額成長了 24%,營業利潤成長了 22%。這反映了公司規模的不斷擴大,與三年前相比,我們現在接受 GLP-1 治療的患者數量增加了約三倍。全年業績可見度的提高導致我們縮小了指導範圍。
I would like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues.
在向我的同事傳達訊息之前,我想先回顧一下我們策略願景的績效亮點。
Starting with our focus on purpose and sustainability. We are now serving more than 43 million patients with our diabetes and obesity treatments. This is an increase of almost 3 million patients compared to 12 months ago. Our total carbon emissions rose by 34% compared to the first nine months of 2023. This was primarily driven by our increased investments in capital expenditure to meet the high demand of our treatments.
從我們對目標和永續性的關注開始。目前,我們正在為超過 4,300 萬名患者提供糖尿病和肥胖治療。與 12 個月前相比,患者人數增加了近 300 萬人。與 2023 年前 9 個月相比,我們的總碳排放量增加了 34%。
To uphold our commitment of being a sustainable employer, we expanded the number of women in senior leadership positions to 41% compared to 40.5% 12 months ago. Across all leadership positions, 47% are held by women.
為了履行我們成為永續雇主的承諾,我們將擔任高階領導職位的女性人數從 12 個月前的 40.5% 增加到 41%。在所有領導職位中,47% 由女性擔任。
In R&D, we had several exciting readouts this quarter, including the Phase III results from SOUL, Stride and Essence. These results are contributing to an already strong body of evidence on the cardiometabolic profile of semaglutide. Martin will come back to this and our overall R&D milestones later.
在研發方面,本季我們發布了一些令人興奮的結果,包括 SOUL、Stride 和 Essence 的 III 期結果。這些結果為索馬魯肽心臟代謝特徵提供了強有力的證據。馬丁稍後將回到這一點以及我們的整體研發里程碑。
The quarterly sales growth reflects solid commercial execution across both operating units. Camilla and Doug will go through the details later. Martin will also go through the financial details, but I'm pleased with the sales growth of 24% in the first 9 months of 2024.
季度銷售成長反映了兩個營運部門穩健的商業執行力。卡米拉和道格稍後將詳細討論細節。 Martin 還將查看財務詳細信息,但我對 2024 年前 9 個月的銷售額增長 24% 感到滿意。
Before we move on to the detailed performance during the first nine months of this year, I would like to update your changes to executive management. Of more than 13 years with Novo Nordisk and more than 7 years as Head of North America Operations, Doug Langa has decided to step aside from his current responsibility by the end of the year and instead take up a role as Senior Adviser to Novo Nordisk executive management, effective January 1, 2025.
在我們討論今年前九個月的詳細業績之前,我想先介紹一下您對執行管理層的變動的最新情況。道格·蘭加(Doug Langa) 在諾和諾德(Novo Nordisk) 工作了13 年多,並擔任北美營運主管7 年多,他決定在今年年底前辭去目前的職務,轉而擔任諾和諾德(Novo Nordisk) 高階主管的高級顧問管理,自 2025 年 1 月 1 日起生效。
I would like to thank Doug for his excellent contribution to Novo Nordisk and look forward to working with him in his new capacity. Dave, Executive Vice President with responsibility for Business Development and Corporate Strategy, will now also take over the responsibility for Novo Nordisk Commercial Operations in US while maintaining his responsibility for global business development.
我要感謝道格對諾和諾德的傑出貢獻,並期待在新的職位上與他合作。負責業務發展和企業策略的執行副總裁戴夫現在也將接管諾和諾德美國商業營運的職責,同時繼續負責全球業務發展。
Since rejoining Novo Nordisk in 2022, Dave has made a substantial impact and build momentum within business development. I'm confident he'll be able to continue this in his new position. His experience with the US business from previous roles within the company further strengthens his fit for this extended role.
自 2022 年重新加入諾和諾德以來,Dave 在業務發展中產生了重大影響並建立了動力。我相信他能夠在新職位上繼續保持這一勢頭。他之前在公司任職期間在美國業務方面的經驗進一步增強了他對這一擴展職位的適應能力。
With that, I'll give the word to Camilla for an update on commercial execution for the first nine months of 2024.
至此,我將轉告卡米拉,了解 2024 年前 9 個月商業執行的最新情況。
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Thank you, Lars, and please turn to the next slide. In the first nine months of 2024, our total sales increased by 24%. The sales growth was driven by both operating units with North American operations growing 31%, international operations growing 15%.
謝謝拉爾斯,請翻到下一張投影片。 2024 年前 9 個月,我們的總銷售額成長了 24%。銷售成長由兩個營運部門推動,其中北美業務成長 31%,國際業務成長 15%。
The US sales growth was positively impacted by gross to net sales adjustments related to prior years. Our GLP-1 sales in diabetes increased by 26%, driven by North America operations growing 32% and international operations growing 16%. Insulin sales increased by 10%, driven by North America operations growing 31% and international operations growing [4%]. Obesity care sales increased 44%, driven by North America growing 32% and international operations growing 95%.
美國銷售成長受到與往年相關的總銷售額與淨銷售額調整的正面影響。在北美業務成長 32% 和國際業務成長 16% 的推動下,我們在糖尿病領域的 GLP-1 銷售額成長了 26%。在北美業務成長 31% 和國際業務成長 [4%] 的推動下,胰島素銷售額成長了 10%。在北美成長 32% 和國際業務成長 95% 的推動下,肥胖護理銷售額成長 44%。
In both geographies, growth was driven by VIGOVI, partly offset by declining Saxenda sales as the market is moving towards once weekly treatments. Rare diseases increased by 3%, driven by a 21% sales increase in North America, partly offset by a 9% decline in the national operations. Please turn to the next slide.
在這兩個地區,成長都是由 VIGOVI 推動的,但隨著市場轉向每週一次的治療,Saxenda 銷售額的下降部分抵消了成長。北美地區銷售額成長 21%,推動罕見疾病成長 3%,但全國業務下降 9% 部分抵銷了這一成長。請翻到下一張投影片。
Before turning to the details of our performance, I would like to talk about the impact of our scaling efforts. Our patient reach across GLP-1 for diabetes and obesity has tripled over the past three years. We have now extended our global reach to around 11.5 million patients according to IQVIA numbers. This means that we have increased our reach by almost 8 million patients in three years. This increase has been driven by our weekly injectable treatments across both North America operations and international operations.
在詳細介紹我們的效能之前,我想先談談我們擴展工作的影響。在過去三年中,我們的患者使用 GLP-1 治療糖尿病和肥胖症的次數增加了兩倍。根據 IQVIA 數據,我們現在已將全球覆蓋範圍擴大到約 1,150 萬名患者。這意味著三年內我們的覆蓋範圍增加了近 800 萬名患者。這一增長是由我們在北美業務和國際業務中每週進行的注射治療所推動的。
Of all paid on GLP-1 across diabetes and obesity, Novo Nordisk is currently supplying treatment to almost two-thirds of those. Going forward, we will continue to pursue an innovation-based strategy driven by the growth of our GLP-1 treatments. This is supported by our continued scaling efforts and in significant investments in the supply chain in the past years.
在所有針對糖尿病和肥胖症的 GLP-1 付費患者中,諾和諾德目前正在為近三分之二的患者提供治療。展望未來,我們將繼續奉行以創新為基礎的策略,推動 GLP-1 療法的發展。這得益於我們過去幾年持續擴大規模的努力和對供應鏈的重大投資。
In order to reach even more patients with our treatments, we also continue to work with portfolio optimizations and product presentations. Please turn to the next slide.
為了讓更多患者接受我們的治療,我們也持續進行產品組合優化和產品展示。請翻到下一張投影片。
Within diabetes care, we are growing 21%, which is faster than the total diabetes market. As a result, our global diabetes value market share has increased over the last 12 months to 33.9%. This is above our strategic aspiration of reaching a third of the global diabetes market value in 2025. The market share increase was driven by market share gains in both North America Operations and International operations. Please turn to the next slide.
在糖尿病照護領域,我們的成長率為 21%,這比整個糖尿病市場的成長速度還要快。因此,我們的全球糖尿病價值市佔率在過去 12 個月中增加至 33.9%。這超出了我們到 2025 年達到全球糖尿病市場價值三分之一的戰略願望。請翻到下一張投影片。
In international operations, diabetes care sales increased by 10% in the first nine months of 2024, which was primarily driven by GLP-1 diabetes sales growing 16%. Novo Nordisk remains the market leader in international operations with a GLP-1 diabetes value market share of almost 67%. Ozempic is still the GLP-1 diabetes market leader with 44% market share.
在國際業務中,2024 年前 9 個月,糖尿病照護銷售額成長了 10%,這主要是由 GLP-1 糖尿病銷售額成長 16% 推動的。諾和諾德仍然是國際業務的市場領導者,其 GLP-1 糖尿病價值市場份額接近 67%。 Ozempic 仍然是 GLP-1 糖尿病市場的領導者,擁有 44% 的市場份額。
We're also pleased to see Rybelsus increasing its market share to almost 18% of the overall diabetes market in international operations, driven by solid uptake across geographies.
我們也很高興看到 Rybelsus 在國際業務中的市場份額在整個糖尿病市場中的份額增加到近 18%,這得益於跨地區的強勁應用。
And with that, I will hand over the word to Doug.
接下來,我將把這個字交給道格。
Douglas Langa - Executive Vice President, North America Operations
Douglas Langa - Executive Vice President, North America Operations
Thank you, Camilla. Please turn to the next slide. Sales in North America were driven by a prescription volume growth of the GLP-1 class above 15% in the third quarter of 2024 compared with the third quarter of 2023, as well as Novo Nordisk market share gains.
謝謝你,卡米拉。請翻到下一張投影片。與 2023 年第三季相比,2024 年第三季 GLP-1 類藥物的處方量成長超過 15%,以及諾和諾德市佔率的成長推動了北美的銷售。
Sales of GLP-1 diabetes care products in the US increased by 33%. The sales increase was driven -- was mainly driven by the continued uptake of Ozempic. Over the past 12 months, Novo Nordisk expanded its market leadership to almost 54% measured on total prescriptions. Total weekly prescriptions have reached around 700,000 and since the supply constraints at the beginning of the year with some impact from utilization management. Please go to the next slide.
GLP-1 糖尿病護理產品在美國的銷售量成長了 33%。銷售額的成長主要是由 Ozempic 的持續吸收所推動的。在過去 12 個月中,諾和諾德將其市場領先地位擴大到以總處方量計算的近 54%。每週處方總數已達到約 70 萬張,自年初供應緊張以來,使用管理產生了一些影響。請轉到下一張投影片。
Wegovy sales increased by 77% globally, driven by a 50% growth in North America operations. The volume growth of the total branded obesity market was 95%. Novo Nordisk sales growth was driven by increased volumes, partially countered by lower realized prices in the US.
在北美業務成長 50% 的推動下,Wegovy 全球銷售額成長了 77%。品牌肥胖市場總量成長了 95%。諾和諾德的銷售成長是由銷售增加所推動的,但部分受到美國實際價格下降的抵銷。
The positive growth development was also reflected in the Wegovy prescription trends in the US, which has now reached almost 215,000 weekly prescriptions. In Q3, we treated more than twice as many patients on Wegovy in the US compared to 12 months ago. In the US, market access continues to increase, and Wegovy currently has coverage for around 55 million people living with obesity.
正面的成長趨勢也反映在美國 Wegovy 處方趨勢上,目前每週處方數量已達到近 215,000 份。第三季度,我們在美國使用 Wegovy 治療的患者數量是 12 個月前的兩倍多。在美國,市場准入不斷增加,Wegovy 目前已覆蓋約 5,500 萬名肥胖症患者。
In international operations, Wegovy sales accelerated in Q3 to DKK7 billion and has now been launched in more than 15 countries, underlining our commitment to reach more patients. We continue to strive to safeguard continuity of care for patients. Next slide, please.
在國際業務中,Wegovy 銷售額在第三季加速達到 70 億丹麥克朗,目前已在超過 15 個國家推出,這突顯了我們涵蓋更多患者的承諾。我們持續努力保障病患照護的連續性。請下一張投影片。
Our rare disease sales increased by 3%. Sales in North America Operations increased by 21%, reflecting the Segovia launch and positive gross adjustments related to prior years in the US. This was partially offset by a 9% sales decrease in international operations.
我們的罕見疾病銷售額成長了 3%。北美業務的銷售額成長了 21%,反映出塞哥維亞的推出以及與前幾年在美國相關的積極總調整。國際業務銷售額下降 9% 部分抵銷了這一影響。
Norditropin supply is gradually improving, and Novo Nordisk is working on reestablishing supply of rare endocrine disorder products. Rare blood disorder sales increased -- me, decreased by 1%, driven by lower NovoSeven and hemophilia A sales. The decline in hemophilia A sales was impacted by reduced demand for legacy products NovoSeven and NovoEight, while aspart uptake continues. This was partly countered by increased hemophilia B sales.
去甲腎上腺素供應正在逐步改善,諾和諾德正在努力重建罕見內分泌失調產品的供應。由於 NovoSeven 和血友病 A 銷售額下降,稀有血液疾病銷售額增加 - 我下降了 1%。 A 型血友病銷售額的下降受到傳統產品 NovoSeven 和 NovoEight 需求減少的影響,而門冬胺酸的吸收仍在持續。 B 型血友病銷售量的增加部分抵消了這一影響。
Now with that, over to you, Martin, for an update on R&D.
現在,馬丁,請您了解研發方面的最新情況。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Thank you, Doug. Please turn to the next slide. Chronic noncommunicable diseases continue to affect millions of people around the world and represents a major public health concern. By leveraging our extensive experience within metabolic diseases, we have deepened our understanding of what semaglutide can do for these patients.
謝謝你,道格。請翻到下一張投影片。慢性非傳染性疾病持續影響著全世界數百萬人,是一個重大的公共衛生問題。透過利用我們在代謝疾病方面的豐富經驗,我們加深了對索馬魯肽對這些患者的作用的了解。
Based on the clinical evidence we have generated so far, it has become evident that the benefits of semaglutide beyond placemic control and beyond weight loss. Semaglutide has consistently demonstrated substantial cardiovascular and kidney risk reductions and functional improvements across several outcome studies. You now include SUSTAIN 6, PIONEER 6, SOUL, Stride and Flow in type 2 diabetes, along with step half-path and selected obesity.
根據我們迄今為止所獲得的臨床證據,很明顯,索馬魯肽的益處超出了控制血糖和減輕體重的範圍。在多項結果研究中,索馬魯肽始終證明可顯著降低心血管和腎臟風險並改善功能。現在,您將 SUSTAIN 6、PIONEER 6、SOUL、Stride 和 Flow 納入第 2 型糖尿病,以及步驟半程和選擇性肥胖。
The benefits of semaglutide have also been demonstrated in addressing knee osteoarthritis in the STEP OA trial, as well as in the metabolic dysfunction associated to stage 2 hepatitis in short MASH in the ESS drive. I will get back to the latter later in this presentation.
在 STEP OA 試驗中,索馬魯肽在解決膝骨關節炎方面以及在 ESS 驅動中的短 MASH 中與 2 期肝炎相關的代謝功能障礙方面也得到了證明。我將在本次演講的稍後部分討論後者。
Looking ahead, we continue to generate further evidence regarding the benefits of semaglutide. For example, this includes the VOC trials in people with Alzheimer's disease and the ASCEND Plus trial in mitigating primary prevention of athlerotic cardiovascular disease in patients with type 2 diabetes and no established cardiovascular disease.
展望未來,我們將繼續提供有關索馬魯肽益處的進一步證據。例如,這包括針對阿茲海默症患者的 VOC 試驗,以及針對第 2 型糖尿病且無明確心血管疾病的患者減輕動脈粥狀硬化性心血管疾病一級預防的 ASCEND Plus 試驗。
Altogether, semaglutide a remarkable molecule capable of addressing multiple comorbidities associated with diabetes and obesity in a holistic way, and we look forward to upcoming trial readouts. Next slide, please.
總而言之,索馬魯肽是一種非凡的分子,能夠以整體方式解決與糖尿病和肥胖相關的多種合併症,我們期待即將到來的試驗結果。請下一張投影片。
In October, Novo Nordisk announced the line results from the SOUL trial. SOUL was a large cardiovascular outcomes trial and was conducted across 33 countries and more than 400 investigational sites. 9,650 people were enrolled and randomized in a 1:1 ratio to receive oral semaglutide 14-milligram or placebo on top of standard of care.
10 月,諾和諾德公佈了 SOUL 試驗的生產線結果。 SOUL 是一項大型心血管結局試驗,在 33 個國家和 400 多個研究地點進行。 9,650 名患者以 1:1 的比例隨機入組,在標準治療的基礎上接受口服 14 毫克索馬魯肽或安慰劑。
The eligibility criteria were designed to include patients with type 2 diabetes with established cardiovascular disease as defined by primary myocardial infarction, stroke, disease and or chronic kidney disease.
資格標準旨在包括患有既定心血管疾病(定義為原發性心肌梗塞、中風、疾病和/或慢性腎臟疾病)的第 2 型糖尿病患者。
Importantly, as part of standard of care, 49% of patients received an ALT-2 inhibitor at some point during the trial with a higher proportion in the placebo group than in the semaglutide group. The primary objective of the trial was to demonstrate the priority of oral semaglutide versus placebo on top of standard of care for prevention of the primary endpoint of major adverse cardiovascular event.
重要的是,作為標準治療的一部分,49% 的患者在試驗期間的某個時間點接受了 ALT-2 抑制劑,安慰劑組的比例高於索馬魯肽組。該試驗的主要目的是證明口服索馬魯肽相對於安慰劑在預防主要不良心血管事件主要終點的護理標準之上的優先性。
The key secondary objectives of the trial was to compare the effects of oral semaglutide to placebo with regards to mortality, renal function, peripheral artery disease, glucose metabolism and body weight. I'm very pleased to announce that SOUL achieved this primary endpoint and that oral semaglutide demonstrated the 14% reduction in major adverse cardiovascular events versus placebo. All components of the primary endpoint contributed to the overall cardiovascular risk reduction.
本試驗的主要次要目標是比較口服索馬魯肽與安慰劑在死亡率、腎功能、週邊動脈疾病、葡萄糖代謝和體重的影響。我非常高興地宣布,SOUL 實現了這一主要終點,口服索馬魯肽與安慰劑相比,主要不良心血管事件減少了 14%。主要終點的所有組成部分都有助於整體心血管風險的降低。
Given the extensive use of SGLT2 inhibitors, which are independently associated with cardiovascular benefits and are included as part of the standard of care, we find that the overall risk reduction on top of standard of care aligns broadly with other semaglutide outcomes trials. We are pleased that for patients who prefer an all GLP-1 agonist, SOUL has demonstrated that oral semaglutide provides a superior cardiovascular risk reduction compared to placebo on top of standard of care.
鑑於 SGLT2 抑制劑的廣泛使用,其與心血管益處獨立相關,並納入標準治療的一部分,我們發現在標準治療基礎上的整體風險降低與其他索馬魯肽結局試驗大致一致。我們很高興地看到,對於喜歡全 GLP-1 激動劑的患者,SOUL 已經證明,在標準護理的基礎上,口服索馬魯肽與安慰劑相比,可以更好地降低心血管風險。
In the trial, oral semaglutide appeared to have a safe and well-tolerated profile. This is in line with previous trials investigating all semaglutide. We expect to file for regulatory approval of a cardiovascular label indication expansion for oral semaglutide around the turn of the year. Next slide, please.
在試驗中,口服索馬魯肽似乎具有安全性和良好的耐受性。這與先前調查所有索馬魯肽的試驗一致。我們預計將在今年年初申請監管部門批准擴大口服索馬魯肽的心血管標籤適應症。請下一張投影片。
On November 1, Novo Nordisk announced the headline results from Part 1 of the ongoing ESSENCE trial. ESSENCE is a Phase III trial evaluating the effect of once weekly subcutaneous semaglutide 2.4 milligrams in add-ons with MASH and moderate to advanced liver fibrosis. ESSENCE is being conducted across 37 countries and over 400 sites. It's a two-part trial with 1,200 MASH participants were randomized in a 2:1 fashion to receive either semaglutide 2.4 milligram or placebo on turbo standard of care for a total of 240 weeks.
11 月 1 日,諾和諾德公佈了正在進行的 ESSENCE 試驗第 1 部分的主要結果。 ESSENCE 是一項 III 期試驗,評估每週一次皮下注射 2.4 毫克索馬魯肽合併 MASH 和中度至晚期肝纖維化的效果。 ESSENCE 正在 37 個國家/地區的 400 多個地點進行。這是一項由兩部分組成的試驗,1,200 名 MASH 參與者以 2:1 的方式隨機接受 2.4 毫克索馬魯肽或安慰劑的渦輪標準護理,為期總共 240 週。
In Part 1, the objective was to demonstrate that treatment with semaglutide 2.4 milligram improves liver histology at week 72 in the first 800 randomized participants. In Part 2, the active is to demonstrate that treatment with semaglutide 2.4 milligrams lower the risk of liver-related clinical events compared to placebo at 240 weeks in 1,200 randomized OpEx.
第 1 部分的目的是證明 2.4 毫克索馬魯肽治療可改善前 800 名隨機參與者在第 72 週時的肝臟組織學特徵。第 2 部分的主要任務是在 1,200 例隨機 OpEx 中證明,與安慰劑相比,240 週時使用 2.4 毫克索馬魯肽治療可降低肝臟相關臨床事件的風險。
Next slide, please. I'm very pleased to announce that the ESSENCE trial achieved both primary endpoints and demonstrate statistically significant and superior improvements in both MASH resolution and liver fibrosis with semaglutide 2.4 milligram compared to placebo.
請下一張投影片。我很高興地宣布,ESSENCE 試驗實現了兩個主要終點,並證明與安慰劑相比,2.4 毫克索馬魯肽在 MASH 消退和肝纖維化方面具有統計意義和卓越的改善。
By week 72 from baseline, 37% of people treated with semaglutide 2.4 milligram achieved improved labor fibrosis with no worsening of Tier 2 hepatitis, while 63% achieved resolution of Tier 2 hepatitis with no worsening of labor fibrosis. To put this into perspective, the ISM Phase III results are the best Phase III results within the MASH area to date.
從基線到第72 週,接受2.4 毫克索馬魯肽治療的患者中,37% 的患者分娩纖維化得到改善,且2 級肝炎沒有惡化,而63% 的患者2 級肝炎得到緩解,且分娩纖維化沒有惡化。從這個角度來看,ISM III 期結果是 MASH 領域迄今為止最好的 III 期結果。
In the trial, semaglutide 2.4 milligram appears to have a safe, well-tolerated profile, which is in line with previous semaglutide 2.4 milligram plans. We're very pleased about the ESSENCE clinical trial results and the potential of semaglutide to help people living with MASH.
在試驗中,索馬魯肽 2.4 毫克似乎具有安全、耐受性良好的特點,這與先前的索馬魯肽 2.4 毫克計劃一致。我們對 ESSENCE 臨床試驗結果以及索馬魯肽幫助 MASH 患者的潛力感到非常高興。
Among the many people with overweight obesity, one in three live with MASH. This has a serious impact on the health and represents a significant unmet need. We believe that with the ESSENCE data, semaglutide is well positioned as a foundational treatment for people with MASH at fibrosis Stage 2 and 3, and offers further additional benefits, including weight loss, glycemic control, cardiovascular risk reduction relevant for this population.
在眾多超重肥胖患者中,三分之一患有 MASH。這對健康產生嚴重影響,並且是一個重大的未滿足的需求。我們相信,根據ESSENCE 數據,索馬魯肽非常適合作為纖維化2 期和3 期MASH 患者的基礎治療,並提供進一步的額外益處,包括與該族群相關的體重減輕、血糖控制、降低心血管風險。
We expect to file for regulatory approvals in the US and EU in the first half of 2025. The detailed results from ESSENCE will be presented at AASLD, the American Association for the Study of Liver Diseases, where two of the ESSENCE trials will continue with expected readout in 2029. Next slide.
我們預計將於 2025 年上半年在美國和歐盟提交監管批准申請。片。
Now I would like to bring your attention to some of the quarterly and upcoming R&D events, which include anticipated trial readouts and initiations for this year.
現在我想提請您注意一些季度和即將舉行的研發活動,其中包括今年預期的試驗結果和啟動。
During Q3 in diabetes, the functional outcomes trial, STRIDE, was successfully completed. This STRIDE trial is a 52-week trial comparing to magnetite 1.0 milligram with placebo on top of standard of care. The trial included people living with type 2 diabetes and peripheral arterial disease with intermittent cloudification and a condition characterized by muscle pace in the legs during physical activity.
在糖尿病第三季度,功能結果試驗 STRIDE 成功完成。這項 STRIDE 試驗是一項為期 52 週的試驗,與標準護理基礎上使用 1.0 毫克磁鐵礦和安慰劑進行比較。該試驗納入了患有第 2 型糖尿病和周邊動脈疾病的患者,這些患者伴隨間歇性混濁以及體力活動期間腿部肌肉節奏加快的症狀。
The primary functional endpoint is measured by constant load treadmill test. It is important to note that the treadmill test is not equivalent to the six-minute walking test on a flat service as we know from, for example, the step heart failure studies. The constant load treadmill test in STRIDE is performed at a single work rate of 3 kilometers per hour at an inclination of 12%, which corresponds to walking up a steep hill at a constant pace.
主要功能終點透過恆定負載跑步機測試來測量。值得注意的是,跑步機測試並不等同於在平坦的地面上進行六分鐘步行測試,正如我們從台階心臟衰竭研究中所了解的那樣。 STRIDE中的恆載跑步機測試以每小時3公里的單次工作速度、12%的坡度進行,相當於以恆定的配速走上陡峭的山坡。
After 52 weeks, the trial achieved its primary endpoint by demonstrating a statistically significant and superior improvement in maximum walking distance of 13% for people treating with semaglutide 1.0 milligram compared to placebo. The 13% improvement represents immediate change in maximum walking distance of 26 meters and a mean change of 40 meters, which is considered clinically relevant.
52 週後,該試驗達到了主要終點,證明與安慰劑相比,使用 1.0 毫克索馬魯肽治療的患者最大步行距離有統計學上顯著且卓越的改善,達到 13%。 13% 的改善意味著最大步行距離立即改變 26 米,平均改變 40 米,被認為具有臨床相關性。
In the semaglutide arm, the walking -- the maximum walking distance increased by 60 -- sorry, 21% from baseline of 185 meters. While in the placebo arm, it increased by 8% from a baseline of 186 meters. Overall, the Stride results are good news for people living with peripheral artery disease and type 2 diabetes whose everyday life is impacted by reducing walking capacity and pain.
在索馬魯肽組中,步行——最大步行距離增加了 60——抱歉,比 185 公尺的基線增加了 21%。而在安慰劑組中,它比 186 公尺的基線增加了 8%。總體而言,Stride 結果對於患有周邊動脈疾病和 2 型糖尿病的患者來說是個好消息,因為他們的日常生活因步行能力下降和疼痛而受到影響。
Novo Nordisk expects to file for regulatory approval of a label expansion for Ozempic in the US and EU in the first half of 2025. The successfully completed SOUL and STRIDE trials adds to the growing body of evidence underlying the cardiovascular benefits of semaglutide.
諾和諾德預計將於 2025 年上半年在美國和歐盟申請監管部門批准 Ozempic 標籤擴充。
To continue within the diabetes domain, a Phase II trial has been initiated with once-weekly subcutaneous and once-daily oral amycretin in people with type 2 diabetes in Q3. And we're anticipating the Phase II readout for monlunabant in diabetes kidney disease in Q4.
為了繼續在糖尿病領域開展工作,第三季已針對第 2 型糖尿病患者啟動了一項 II 期試驗,每週一次皮下注射和每日一次口服阿黴素。我們預計 monlunabant 治療糖尿病腎病變的 II 期試驗結果將在第四季度公佈。
Lastly, within diabetes, we are awaiting the regulatory decisions on the submitted flow data in US and EU in the first half of 2025. Within obesity, the European Medicines Agency has adopted a positive opinion for an update of the Wegovy label in EU.
最後,在糖尿病方面,我們正在等待 2025 年上半年美國和歐盟對提交的流量數據做出的監管決定。
The labels update incorporates data showing that Wegovy, when added to standard of care, can reduce heart failure-related symptoms and improve physical limitations and exercise function in people with obesity-related FP with overdue to diabetes.
標籤更新包含的數據顯示,當將 Wegovy 添加到標準護理中時,可以減少因肥胖相關的 FP 且逾期糖尿病的患者的心臟衰竭相關症狀,並改善身體限制和運動功能。
The positive opinion is based on results from the STEP HFpEF and the STEP HFpEF DM trials. Third, a positive opinion was also issued based on data from the STEP 9 file in people with obesity and knee or throat arthritis.
此正面意見是基於 STEP HFpEF 和 STEP HFpEF DM 試驗的結果。第三,根據 STEP 9 文件中肥胖和膝關節炎或咽喉關節炎患者的數據,也發表了正面的意見。
In Q3, the Phase IIa trial with modular was completed. As previously communicated, we expect to initiate a larger Phase IIb trial in obesity to further investigate dosing and the safety profile of monlunabant over a longer duration in a global population in 2025.
第三季度,完成了模組化IIa期試驗。如同先前所傳達的,我們預計將於 2025 年啟動一項更大規模的肥胖 IIb 期試驗,以進一步研究 monlunabant 在全球人群中較長持續時間內的劑量和安全性。
We have also initiated a Phase I trial with once weekly subcutaneous [amylin 355]. The 12-week trial is investigating safety, tolerability, pharmacokinetics and pharmacodynamics of different doses of Amlin 355 in people with overweight obesity.
我們也啟動了每週一次皮下注射 [amylin 355] 的 I 期試驗。這項為期 12 週的試驗正在調查不同劑量的 Amlin 355 在超重肥胖族群中的安全性、耐受性、藥物動力學和藥效學。
Looking ahead, later in Q4, we anticipate the first Phase III results for (inaudible), namely from the REDEFINE 1 study. The second pivotal trial for (inaudible) REDEFINE 2 will read out in the first half of 2025. As we approach the year-end, we're also looking forward to the Phase III results for STEP UP involving semaglutide 7.2 milligram.
展望未來,我們預計將在第四季度晚些時候獲得第一個 III 期結果(聽不清楚),即來自 REDEFINE 1 研究的結果。 (聽不清楚)REDEFINE 2 的第二次關鍵試驗將於 2025 年上半年公佈。
And finally, in the first half of '25, we're expecting the Phase I readout for subcutaneous amucretin in obesity. Within rare disease in Q3, we have initiated a Phase I trial with innerweights and oral once-daily antibody fragment for the treatment of hemophilia A.
最後,在 25 年上半年,我們期待皮下注射 amucretin 治療肥胖症的 I 期結果。在第三季的罕見疾病中,我們啟動了一項 I 期試驗,使用體重和每日一次口服抗體片段來治療 A 型血友病。
Moreover, different Tier 5 trials with MIMA was successfully completed. The trial was an open-label safety study in people with hemophilia A and demonstrated that switching from emicizumab treatment to [mesosomal] treatment appear to be safe and well tolerated.
此外,MIMA 的不同 Tier 5 試驗也已成功完成。該試驗是一項針對 A 型血友病患者的開放標籤安全性研究,並證明從艾美珠單抗治療轉為 [mesosomal] 治療似乎是安全且耐受性良好的。
Lastly, within rare disease, we have successfully completed the Phase II interim part of the viscous Phase II/III trial in people with sickle cell disease. The interim analysis is proof of concept for etavopivat in single cell disease and etavopivat appear to have a safe and well-tolerated profile. The Phase III part of the ubiscos trial is currently ongoing with the expected readout in 2026.
最後,在罕見疾病領域,我們已經成功完成了針對鐮狀細胞疾病患者的黏性 II/III 期試驗的 II 期中期部分。中期分析證明了 etavopivat 在單細胞疾病中的概念,並且 etavopivat 似乎具有安全且耐受性良好的特徵。 ubiscos 試驗的 III 期部分目前正在進行中,預計將於 2026 年公佈結果。
With that, over to you, Karsten.
就這樣,交給你了,卡斯滕。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Thank you, Martin. Please turn to the next slide. In the first nine months of 2024, our sales grew by 23% in Danish kroner and 24% at constant exchange rates, driven by both operating units. In the US, sales growth was positively impacted by gross to net sales adjustments related to prior years and phasing of rebates in 2023.
謝謝你,馬丁。請翻到下一張投影片。 2024 年之前 9 個月,在兩個營運部門的推動下,我們的銷售額以丹麥克朗計算增長了 23%,以固定匯率計算增長了 24%。在美國,銷售成長受到與往年相關的總銷售額與淨銷售額調整以及 2023 年分階段回扣的正面影響。
Sales growth has resulted in periodic supply constraints and related drug shortage notifications across a number of products and geographies. The gross margin increased to 84.6% compared to 84.5% in 2023. The increase is mainly driven by positive price impact due to the gross to net sales adjustments related to prior years in the US and a positive product mix. This is partially funded by costs related to the ongoing capacity expansions.
銷售成長導致許多產品和地區出現週期性供應限制和相關藥品短缺通知。毛利率從 2023 年的 84.5% 增至 84.6%。這部分資金來自與持續產能擴張相關的成本。
Sales and distribution costs increased by 10% in both Danish kroner and at constant exchange rates. In North America operations, the cost increase is mainly driven by promotional activities related to Wegovy, while in international operations, the increase is mainly related to obesity care market development activities, Wegovy launch activities as well as promotional activities for GLP-1 diabetes products.
以丹麥克朗和固定匯率計算的銷售和分銷成本增加了 10%。在北美業務中,成本增加主要由Wegovy相關的促銷活動推動,而在國際業務中,成本增加主要與肥胖護理市場開發活動、Wegovy上市活動以及GLP-1糖尿病產品的促銷活動有關。
Additionally, the increase in sales and distribution costs is impacted by adjustments to legal provisions in the second quarter of 2023. Research and development costs increased by 56%, both measured in Danish kroner and at constant exchange rates. The increase in costs is mainly reflecting increased late-stage clinical trial activity and increased early research activities as well as the impairment loss related to intangible assets, including ocedurenone at DKK5.7 billion.
此外,銷售和分銷成本的增加也受到 2023 年第二季法律規定調整的影響。成本的增加主要反映了後期臨床試驗活動的增加和早期研究活動的增加,以及與無形資產相關的減損損失,其中包括 57 億丹麥克朗的 ocedurenone。
Administration costs increased by 9%, both in Danish kroner and at constant exchange rates. Operating profit increased by 21% measured in Danish kroner and by 22% at constant exchange rates. Operating profit is impacted by the impairment loss related to Osidurinon of DKK5.7 billion. As a consequence, EBITDA increased by 28% measured in Danish kroner and by 30% at constant exchange rates.
以丹麥克朗和固定匯率計算的管理成本增加了 9%。以丹麥克朗計算的營業利潤成長了 21%,以固定匯率計算則成長了 22%。營業利潤受到與 Osidurinon 相關的 57 億丹麥克朗減損損失的影響。因此,以丹麥克朗計算的 EBITDA 成長了 28%,以固定匯率計算則成長了 30%。
Net financial items showed a net gain of DKK32 million compared to a net gain of DKK1.246 billion last year. The effective tax rate was 20.6% in the first 9 months of 2024 compared to 19.9% in the first nine months of 2023.
淨金融計畫淨收益為 3,200 萬丹麥克朗,去年的淨收益為 12.46 億丹麥克朗。 2024 年前 9 個月的有效稅率為 20.6%,而 2023 年前 9 個月的有效稅率為 19.9%。
Net profit increased by 18%, and diluted earnings per share increased by 19% to DKK16.29. Net profit and diluted earnings per share are negatively impacted by the DKK5.7 billion impairment of ocedurenone. Free cash flow realized in 2024 was DKK71.8 billion compared to DKK75.6 billion in the first nine months of 2023.
淨利成長 18%,攤薄後每股收益成長 19%,達 16.29 丹麥克朗。淨利和稀釋每股盈餘受到 ocedurenone 57 億丹麥克朗減損的負面影響。 2024 年實現的自由現金流為 718 億丹麥克朗,而 2023 年前 9 個月為 756 億丹麥克朗。
The lower free cash flow reflects increasing capital expenditure partially countered by net cash generated from operating activities. Capital expenditure for property, plant and equipment was DKK31.1 billion compared to DKK16.4 billion in 2023. This was primarily driven by investments in additional capacity for API, production and fill/finish capacity for both current and future injectable and oral products.
自由現金流下降反映了資本支出的增加,部分被經營活動產生的淨現金抵銷。物業、廠房和設備的資本支出為311 億丹麥克朗,而2023 年為164 億丹麥克朗。 。
The extensive increase in capital expenditure underscores our dedication to internal growth initiatives as part of our capital allocation strategy. Our number one priority is to invest in internal growth opportunities followed by returning capital to shareholders through dividends and pursuing business development of duties.
資本支出的大幅增加凸顯了我們致力於內部成長計劃,作為我們資本配置策略的一部分。我們的首要任務是投資內部成長機會,然後透過股息向股東返還資本並追求業務發展。
Finally, we view the share buyback program as a flexible measure contingent on the first 3 priorities. This allows us to effectively distribute potential excess cash. Please go to the next slide.
最後,我們將股票回購計畫視為取決於前三個優先事項的彈性措施。這使我們能夠有效地分配潛在的多餘現金。請轉到下一張投影片。
We continued the growth momentum in 2024 and have narrowed our sales growth guidance to between 23% and 27% at constant exchange rates. The guidance reflects expectations for sales growth in both North America Operations and International operations, mainly driven by volume growth of GLP-1 based treatments for both obesity and diabetes care.
我們在 2024 年持續維持成長勢頭,並將以固定匯率計算的銷售成長指引縮小至 23% 至 27%。該指引反映了對北美業務和國際業務銷售成長的預期,這主要是由基於 GLP-1 的肥胖和糖尿病治療療法的銷售成長所推動的。
Following the expectation of continued volume growth and capacity limitations at some manufacturing sites, the outlook also reflects continued periodic supply constraints and related drug shortage notifications across a number of products and geographies. Novo Nordisk is investing in internal and external capacity to increase supply both short and long term.
在一些生產基地銷售持續成長和產能限制的預期之後,前景也反映出一些產品和地區持續的周期性供應限制和相關藥品短缺通知。諾和諾德正在投資內部和外部產能,以增加短期和長期供應。
Operating profit growth is now expected to be between 21% and 27% at constant exchange rates. Capital expenditure is still expected to be around DKK35 billion in 2024, reflecting expansion of the global supply chain. The free cash flow is now expected to be between DKK57 million and DKK65 billion, reflecting the sales growth, a favorable impact from rebates in the US countered by investments in capital expenditure.
以固定匯率計算,目前預計營業利潤成長在 21% 至 27% 之間。預計 2024 年資本支出仍約為 350 億丹麥克朗,反映了全球供應鏈的擴張。目前,自由現金流預計在 5,700 萬丹麥克朗至 650 億丹麥克朗之間,反映了銷售成長、美國回扣的有利影響以及資本支出投資的抵銷。
The updated cash flow expectation mainly reflects phasing of payments related to rebates in the US as well as timing of investments related to capital expenditure. Income under the 340B program in the US has been partially recognized. One ruling from the US Court of Appeals for the Seventh Circuit remains pending and along with the DC Circuit, ruling may be subject to further discretionary appellate review before the US Supreme Court.
更新後的現金流量預期主要反映了與美國回扣相關的付款階段以及與資本支出相關的投資時機。美國340B計劃下的收入已部分確認。美國第七巡迴上訴法院的一項裁決仍懸而未決,與華盛頓特區巡迴法院一樣,該裁決可能需要接受美國最高法院進一步的酌情上訴審查。
Depending on the outcome of any subsequent rulings and appeals in these matters, there may be a material impact on Novo Nordisk's financial position, net sales and cash flow. The Catalent transaction is still expected to close towards the end of the year and financial impacts have not been included in the financial guidance. Consented on the timing of closing, the acquisition is expected to have a low single-digit negative impact on operating profit growth in 2024 and low to mid-single-digit impact in 2025.
根據這些事項的後續裁決和上訴的結果,可能會對諾和諾德的財務狀況、淨銷售額和現金流產生重大影響。康泰倫特交易預計仍將在年底前完成,財務影響尚未納入財務指引中。在完成時間達成協議後,預計此次收購將對 2024 年營業利潤成長產生低個位數的負面影響,並在 2025 年產生低至中個位數的影響。
That covers the outlook for 2024. Now back to you, Lars.
這涵蓋了 2024 年的展望。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Thank you, Karsten. Please turn to the final slide. We are very pleased with the sales growth in the first 9 months of 2024. The growth is driven by increasing demand for our GLP-1 based diabetes and obesity treatments, reflecting the continued scaling of our supply chain. And we are serving more patients than ever before.
謝謝你,卡斯滕。請翻到最後一張投影片。我們對 2024 年前 9 個月的銷售成長感到非常滿意。這一增長是由對我們基於 GLP-1 的糖尿病和肥胖治療藥物的需求不斷增長推動的,反映了我們供應鏈的持續擴展。我們正在為比以往更多的患者提供服務。
Then R&D, we're very pleased with the readouts across our semaglutide portfolio, including the SOUL trial in people living with diabetes and cardiovascular disease, and the ESSENCE trial in people living with MASH. Lastly, we look forward to a number of exciting readouts over the next quarter.
然後是研發,我們對索馬魯肽產品組合的結果非常滿意,包括針對糖尿病和心血管疾病患者的 SOUL 試驗,以及針對 MASH 患者的 ESSENCE 試驗。最後,我們期待下個季度出現一些令人興奮的數據。
With that, I would like to hand the word back to Jacob.
說到這裡,我想把話交還給雅各。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Lars. Next slide, please. With that, we are now waiting for the Q&A. We kindly ask all participants to limit her or himself to one or maximum two questions, including sub questions. Operator, we are now ready to take the first question.
謝謝你,拉爾斯。請下一張投影片。至此,我們現在正在等待問答。我們懇請所有參與者只提出一個或最多兩個問題,包括子問題。接線員,我們現在準備回答第一個問題。
Operator
Operator
Richard Parkes, BNP Paribas Exane.
理查德‧帕克斯 (Richard Parkes),法國巴黎銀行 Exane。
Richard Parkes - Analyst
Richard Parkes - Analyst
I'm going to ask one on CagriSema. I think in the press, you've been reiterating your confidence in hitting the 25% weight loss by. I get lots of questions from investors of how you bridge between that number and the number that was reported in earlier clinical trials is obviously at an earlier time point. So I know you've mentioned that's based on internal modeling assumptions. But can you help us understand a little bit more in terms of the details that underpins that modeling and again, your confidence on hitting that.
我要去 CagriSema 問一個。我認為在媒體上,您一直在重申您對實現 25% 減肥目標的信心。我從投資者那裡得到了很多問題,關於如何在這個數字和早期臨床試驗中報告的數字之間建立橋樑,顯然是在更早的時間點。所以我知道您提到這是基於內部建模假設的。但是您能否幫助我們更了解支撐該建模的細節,以及您實現這一目標的信心。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thanks a lot for that, Richard. That goes to you, Martin, on the high level CagriSema expectations.
非常感謝,理查德。馬丁,這就是您對 CagriSema 的高水平期望。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Yes. Thank you very much, Richard. So first of all, it's important to call out we have no new data. And therefore, our confidence remains to be the same. The way that we think about this is that we have three sets of data to look at from a modeling perspective.
是的。非常感謝你,理查德。首先,重要的是要指出我們沒有新數據。因此,我們的信心保持不變。我們思考這個問題的方式是,我們從建模的角度來看三組資料。
One is Phases I and II for CagriSema mono therapy, then Phase I/II for obesity and Kagoshima and thirdly, the Phase II mile for Kagoshima in type 2 diabetes. We can then apply our models, I would say, on this based on our extensive knowledge and experience within the obesity space, and we arrive then at the 25% weight loss.
第一個是 CagriSema 單一療法的 I 期和 II 期,然後是針對肥胖和鹿兒島的 I/II 期,第三是鹿兒島 2 型糖尿病的 II 期。我想說的是,我們可以基於我們在肥胖領域的豐富知識和經驗來應用我們的模型,然後我們就能達到 25% 的減肥效果。
Nothing has really changed there. I've not seen any new data and basically, a couple of hours after I've seen that, you will be in the know. So that's where we are today.
那裡什麼都沒有真正改變。我還沒有看到任何新數據,基本上,在我看到這些數據幾個小時後,您就會知道了。這就是我們今天的處境。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Martin, and thank you, Richard. We are ready for the next question, please.
謝謝你,馬丁,謝謝你,理查。我們已經準備好回答下一個問題了。
Operator
Operator
Sachin Jain, Bank of America.
薩欽‧賈恩 (Sachin Jain),美國銀行。
Sachin Jain - Analyst
Sachin Jain - Analyst
Sachin Jain, Bank of America. Two questions, please. Firstly, on Catalent, you've noted confidence and deal close by year-end. I wonder if you could just give any more color on the process that drives that confidence, and confidence no delays or preliminary injunctions. There's been a lot of market debate there.
薩欽‧賈恩 (Sachin Jain),美國銀行。請教兩個問題。首先,在康泰倫特,您注意到年底前的信心和交易。我想知道您是否可以對推動這種信心的過程提供更多的色彩,並且信心沒有延遲或初步禁令。那裡有很多市場爭論。
And then secondly, given the limited visibility we have on supply, I wonder if you're willing to just give some early indications of '25 growth and key pushes and pulls as we think about next year.
其次,鑑於我們對供應的了解有限,我想知道您是否願意提供一些有關 25 年增長的早期跡像以及我們對明年的考慮的關鍵推動和拉動。
I'm asking for a guide for perhaps a high-level commentary that you've made before, perhaps you could frame 2H '24, a decent indicator of growth in '25 or '24 absolute growth continuing to '25. Any high-level comments you'd be willing to make.
我正在尋求一份指南,也許您之前做過一個高水平的評論,也許您可以以框架 2H '24,一個不錯的 '25 增長指標或 '24 絕對增長持續到 '25。您願意發表的任何高層評論。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you for the question, Sachin. Both of those to you, Karsten, firstly on the Catalent transaction and then on supply momentum in Novo Nordisk.
謝謝你的提問,薩欽。卡斯滕,這兩個問題首先是康泰倫特交易,然後是諾和諾德的供應勢頭。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes. Thank you for those two relevant questions. So as to Catalent, we still expect the deal to close towards the end of this year. And that statement is based on our ongoing interactions with the regulators in the different geographies.
是的。謝謝您提出這兩個相關問題。至於康泰倫特,我們仍然預計該交易將在今年年底前完成。該聲明是基於我們與不同地區監管機構的持續互動。
So from the get-go, we assessed that this transaction would not violate any antitrust legislation. And since we have produced a lot of documents and had a number of attractions with regulators, and it's basically based on those infections that we believe, while not concluded at this point, we still believe that the deal will close by end of this year.
因此,我們從一開始就評估這筆交易不會違反任何反壟斷立法。由於我們已經製作了大量文件,並對監管機構產生了許多吸引力,基本上是基於我們認為的那些感染情況,雖然目前尚未得出結論,但我們仍然相信交易將在今年年底完成。
As to supply and 2025 guidance. Then first of all, it's important to note, as we also showed in one of the prior slides by Camilla, that we scale the number of people we've reached with GLP-1s by a factor three over the last three years and now have around two-thirds of the market of GLP-1 treatments on Novo products. And that's scaling.
至於供應和 2025 年指導。首先,值得注意的是,正如我們在 Camilla 之前的一張幻燈片中所展示的那樣,我們在過去三年中將 GLP-1 覆蓋的人數擴大了三倍,現在已經約佔Novo 產品GLP-1治療市場的三分之二。這就是規模化。
Of course, we're focused on continuing that type of scaling into the coming years. And as to the more detailed 2025 outlook, the way I would frame it is that when you look at our absolute growth last year in 2023, which turned into a 36% growth rate last year. That absolute growth is somewhat similar to the absolute growth we're delivering this year, yielding a mid-20s like growth.
當然,我們的重點是在未來幾年繼續進行這種類型的擴展。至於更詳細的 2025 年展望,我的框架方式是,當你看看我們去年 2023 年的絕對成長時,去年的成長率為 36%。這種絕對成長與我們今年實現的絕對成長有些相似,產生了 20 多歲左右的成長。
So to get a sense for what could grow mathematically maybe next year, then if you take that magnitude and apply it to a higher base, namely this year's sales, and then adjust for the tailwind we've had from favorable US gross to net adjustments related to prior years, then you end in the high teens in terms of sales growth next year against a forward-looking statement mathematically based, and we'll come back with more detailed guidance come early February 2025.
因此,為了了解明年可能會出現的數學成長,那麼如果你採用這個幅度並將其應用於更高的基數,即今年的銷售額,然後根據我們從有利的美國毛利率到淨調整的順勢進行調整與往年相關,那麼與基於數學的前瞻性陳述相比,明年的銷售成長將達到兩位數,我們將在2025 年2 月初提供更詳細的指導。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Karsten, and thank you, Sachin, for those two questions. With that, we are ready for the next set of questions, please.
謝謝你,卡斯滕,謝謝你,薩欽,提出這兩個問題。這樣,我們就準備好回答下一組問題了。
Operator
Operator
Louise Chen, Cantor.
路易絲·陳,康托爾。
Louise Chen - Analyst
Louise Chen - Analyst
So I had two. First one, I wanted to ask you what your filing strategy for ESSENCE may be. Are you looking at label expansion or filing it as a new product? And then on maluumab, what do you think the Street is missing here? You showed some favorable data, but I guess the Street isn't really picking up on that. So what do you think is good about your studies here that people haven't really appreciated?
所以我有兩個。首先,我想問您 ESSENCE 的歸檔策略是什麼。您是否正在考慮擴展標籤或將其作為新產品歸檔?然後,關於 maluumab,您認為華爾街在這裡缺少什麼?你展示了一些有利的數據,但我猜華爾街並沒有真正注意到這一點。那麼你認為你在這裡學習的哪些優點是人們沒有真正欣賞的呢?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you for those two questions, Louise. Perhaps firstly, on ESSENCE data, Martin and Camilla can add a little bit on commercial potential, and then we move back to Martin for monlunabant data.
謝謝你提出這兩個問題,路易絲。也許首先,在 ESSENCE 資料上,Martin 和 Camilla 可以增加一點商業潛力,然後我們回到 Martin 來取得 monlunabant 資料。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
So the regulatory framework in the MASH space is that regulators at the end of the day, require hard end points, hard liver endpoints, but also hard cardiovascular endpoints because these patients also die from cardiovascular disease.
因此,MASH 領域的監管框架是,監管機構最終需要硬終點、硬肝臟終點,而且還需要硬心血管終點,因為這些患者也死於心血管疾病。
However, the authorities also acknowledge that there's a huge unmet need in this space. And therefore, the agreement that we have with the regulators is that we could do this interim analysis based on liver histology, liver biopsies and histology on those liver biopsies, and we can get a conditional regulatory approval if we see improvement in steatosis and fibrosis.
然而,當局也承認這一領域存在巨大的未滿足需求。因此,我們與監管機構達成的協議是,我們可以根據肝臟組織學、肝臟活檢和這些肝臟活檢的組織學進行臨時分析,如果我們看到脂肪變性和纖維化有所改善,我們可以獲得有條件的監管批准。
So based on the data that we've announced and that we've seen we aim to do a regulatory filing to get the approval for MASH and thereby also continuing the ESSENCE trial to get the harder endpoints in the coming years that the regulators will require. I'll leave it to Camilla to talk to the commercial position.
因此,根據我們已經宣布的數據和我們看到的數據,我們的目標是提交監管備案以獲得 MASH 的批准,從而繼續 ESSENCE 試驗,以獲得監管機構要求的未來幾年更難的終點。我將讓卡米拉來討論商業立場。
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Yes. Hello there, Martin. So there's no doubt that there's a very big unmet need in this area, and we expect that around 22 million people are living with MASH F2 to F4. And this is, of course, in the US alone.
是的。你好,馬丁。因此,毫無疑問,該領域存在非常大的未滿足需求,我們預計約有 2,200 萬人正在使用 MASH F2 至 F4。當然,這只是在美國。
So no doubt that there is a big unmet need. We, of course, expect that in the last few years, there's been a better understanding of the importance of treating serious chronic diseases related also to obesity. And we know that, of course, also diagnostic space has a big impact here.
因此,毫無疑問,存在著巨大的未滿足需求。當然,我們期望在過去幾年中,人們對治療與肥胖相關的嚴重慢性疾病的重要性有了更好的認識。當然,我們知道診斷空間在這裡也有很大的影響。
So of course, that in itself is something that we're also focusing on from a commercial point of view via partnerships to make sure that the diagnostics are in place, both, you can say, blood-based but also scanning based so that we don't have to rely on only liver biopsies.
當然,這本身也是我們從商業角度透過合作關係來關注的事情,以確保診斷到位,你可以說,既可以基於血液,也可以基於掃描,以便我們不必僅依賴肝臟活檢。
But of course, it's important that all of this works out towards the launch. So I think all in all, we feel that here, we have an important asset that can make a big difference in an area where they previously has been very limited treatment.
但當然,重要的是所有這些都有助於發布。所以我認為總而言之,我們覺得在這裡,我們擁有一項重要的資產,可以在以前受到非常有限的治療的領域中產生巨大的變化。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Camilla, and thank you, Martin. And then we'll go back to you, Martin, for question number two, malunivine data and how that informs us going forward?
謝謝你,卡米拉,謝謝你,馬丁。然後我們會回到你,馬丁,詢問第二個問題,malunivine 數據以及它如何指導我們前進?
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Yes, absolutely. So I can't speculate to what other people have been thinking about the mollunobant data. But I can tell you what we've been thinking about it.
是的,絕對是。所以我無法推測其他人對 mollunobant 數據的看法。但我可以告訴你我們一直在想什麼。
We have all long communicated two things. First of all, obviously, we have a high focus on the safety aspects of this class of drugs. There is a history, and we need to make sure that we only introduce safe drugs into the market in this business and all other spaces.
我們長期以來一直在傳達兩件事。首先,顯然我們高度關注此類藥物的安全性。這是有歷史的,我們需要確保我們只將安全的藥物引入這個行業和所有其他領域的市場。
And secondly, I think people tend to forget that we've all along to that and we would conduct a Phase IIb trial to really establish the safety profile of malunobant before we progress into further development. And we indicated that actually before we saw the data.
其次,我認為人們往往會忘記我們一直在這樣做,並且在我們進行進一步開發之前,我們將進行 IIb 期試驗,以真正確定 malunobant 的安全性。我們實際上在看到數據之前就指出了這一點。
Then we saw the data, and they actually confirmed that we saw a good efficacy profile of mollunovant. We also saw both gastrointestin, but also some neuropsychiatric events increasing with those. On the efficacy part, it was very clear that we were high on the dose response and exposure response curve, indicating maybe that two high doses have been set from a clinical and from a commercial perspective.
然後我們看到了數據,他們實際上證實了我們看到了 mollunovant 的良好療效。我們也看到胃腸道事件以及一些神經精神事件也隨之增加。在功效部分,很明顯我們在劑量反應和暴露反應曲線上都很高,這表明可能從臨床和商業角度設定了兩個高劑量。
And therefore, we can actually say that this works from a weight loss perspective, but we have to work with the dosing to mitigate potential safety issues.
因此,我們實際上可以說,從減肥的角度來看,這是有效的,但我們必須調整劑量,以減輕潛在的安全問題。
And that is exactly what we intend to do in the Phase IIb trial. So from our perspective, still a potential. It's still high risk. We communicated that all along as well. But something that we will, as planned, continue to investigate further in the Phase IIb trial.
這正是我們打算在 IIb 期試驗中要做的事。所以從我們的角度來看,仍然有潛力。風險還是很高的。我們也一直在傳達這一點。但我們將按計劃在 IIb 期試驗中繼續進一步研究。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thanks a lot, Martin, and also thank you to you, Louise. Then we are ready for the next set of questions, please.
非常感謝,馬丁,也謝謝你,路易絲。然後我們準備好回答下一組問題。
Operator
Operator
Michael Nedelcovych, TD Cowen.
邁克爾·內德爾科維奇,TD·考恩。
Michael Nedelcovych - Analyst
Michael Nedelcovych - Analyst
I have two. The first is regarding the (technical difficulty)
我有兩個。第一個是關於(技術難度)
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
I think you fell out, Michael. Are you able to hear us?
我想你已經鬧翻了,麥可。你聽得到我們說話嗎?
Operator
Operator
Would you like to go onto the next question?
您想繼續下一個問題嗎?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Yes, please.
是的,請。
Operator
Operator
Jo Walton, UBS.
喬沃爾頓,瑞銀集團。
Jo Walton - Analyst
Jo Walton - Analyst
My question firstly on marketing costs. So you've been -- marketing costs were up 10% year-to-date, but up much more strongly in the third quarter. I wonder if you could tell us how competitive you think the situation is in the US. Given there's such strong demand, but there is also increasing supply, how should we be thinking about your marketing costs going forward? And I'm obviously thinking about your longer-term leverage here.
我的問題首先是關於行銷成本。年初至今,行銷成本上漲了 10%,但第三季的漲幅更為強勁。我想知道您能否告訴我們您認為美國的競爭情況如何。鑑於需求如此強勁,但供應也不斷增加,我們應該如何考慮您未來的行銷成本?我顯然正在考慮你在這裡的長期影響力。
And within that, can I also ask your latest view on what proportion of the market is being served by compounded product. So presumably, now that you are out of shortage in the US, you would be expecting that compounded market to go away. So I'm just wondering if you can -- if you are confident that you can absorb that demand if it comes back to look at the brand product.
其中,我還可以詢問您對複合產品所服務的市場比例的最新看法嗎?因此,既然美國已經擺脫了短缺,那麼您可能會期望複合市場會消失。所以我只是想知道你是否可以——如果你有信心在回頭看品牌產品時能夠吸收這種需求。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you for those two questions, Joe. For the first one, I'll hand over to Doug on the promotional efforts behind Wegovy. And after that, we turn to Lars for overall on compounding. Doug, over to you.
謝謝你提出這兩個問題,喬。對於第一個問題,我將把 Wegovy 背後的推廣工作交給 Doug。之後,我們向拉斯求助,了解複合的整體情況。道格,交給你了。
Douglas Langa - Executive Vice President, North America Operations
Douglas Langa - Executive Vice President, North America Operations
Yes. Thanks, Joe. I appreciate the question. Maybe as a starting point, I'd like to say that certainly pleased with the overall efforts, and it was another strong quarter. I mean we continue to see leadership and market access in both diabetes and obesity. We're driving market growth in both segments. And I think that both products are performing well.
是的。謝謝,喬。我很欣賞這個問題。也許作為一個起點,我想說的是,我對整體努力當然感到滿意,這又是一個強勁的季度。我的意思是,我們繼續看到糖尿病和肥胖症領域的領導地位和市場准入。我們正在推動這兩個領域的市場成長。我認為這兩種產品都表現良好。
And to your question specifically, we'll continue to invest in those markets appropriately. And I do believe that those investments are competitive and they are appropriate, and we continue to evaluate, and we invest as appropriate as we see the market growth.
具體到你的問題,我們將繼續對這些市場進行適當的投資。我確實相信這些投資具有競爭力且是適當的,我們將繼續評估,並根據我們看到的市場成長進行適當的投資。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Doug. Then over to you, Lars, on compounding.
謝謝你,道格。然後,拉斯,關於複利的事情就交給你了。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yes. Thank you, Jo, for the question. So I would say our first and foremost concern about compounding is really the product quality what patients are exposed to. And I think that's quite alarming what we see of safety reports, even hospitalization and death. So we feel an obligation for taking action on this.
是的。謝謝喬提出的問題。因此,我想說,我們對複合藥物的首要關注實際上是患者接觸到的產品品質。我認為我們看到的安全報告,甚至住院和死亡的情況非常令人震驚。因此,我們感到有義務對此採取行動。
So patients who seek treatment and perhaps believe they're getting a quality product from Novo Nordisk is not misled And with that, say, believe, treat themselves for something that's potentially hampful. So we have in dialogue with the FDA based on our increasing supply to the US of Wegovy, including increasing supply of the state doses agreed with the FDA that this is increasing to a magnitude where they can take away the drug shortage notification also on the state dose.
因此,尋求治療並可能相信自己從諾和諾德獲得優質產品的患者不會被誤導。因此,我們與 FDA 進行了對話,基於我們增加對美國 Wegovy 的供應,包括增加州劑量的供應,FDA 同意,這增加到他們可以取消該州藥物短缺通知的程度劑量。
So we are off for all doses. And that, of course, means that we will see, say, an uptick in the US in the coming weeks in terms of supply.
所以我們停止了所有劑量的接種。當然,這意味著我們將在未來幾週內看到美國的供應量增加。
To your question about what share compounders take. Honestly, we don't know. There are hundreds, if not thousands of potential compounders in the US, and we have limited visibility to what the supply my understanding is that it's primarily in, say, the Internet, say, direct-to-consumer space and we promote our products as products for people living with serious chronic disease. And they should really be helped by insurance.
關於你關於複利者拿什麼股份的問題。老實說,我們不知道。在美國有數百個甚至數千個潛在的複合商,我們對供應的了解有限,我的理解是,它主要是在互聯網上,比如說,直接面向消費者的領域,我們將我們的產品推廣為患有嚴重慢性疾病的人提供的產品。他們確實應該得到保險的幫助。
And I don't think these products are in the classical insurance channel. So we feel confident in our ability to scale and treat more and more patients. But for us, it's really not about a business opportunity. It's more about the safety for patients and no patient should believe that they get access to semaglutide and not being the case because we're the only one producing an approved version of semaglutide.
我不認為這些產品屬於經典保險通路。因此,我們對擴大規模和治療越來越多患者的能力充滿信心。但對我們來說,這確實不是一個商業機會。這更多的是關於患者的安全,任何患者都不應該相信他們可以獲得索馬魯肽,但事實並非如此,因為我們是唯一一家生產經批准版本的索馬魯肽的公司。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Lars. So two areas that have our utmost focus.
謝謝你,拉爾斯。因此,我們最關注的兩個領域。
Thanks, Jo. And we are now ready for the questions, please.
謝謝,喬。我們現在準備好回答問題了。
Operator
Operator
Richard Vosser, JPMorgan.
理查沃瑟,摩根大通。
Richard Vosser - Analyst
Richard Vosser - Analyst
A couple, please. So firstly, just a bit more color if possible on the ex-US supply of Ozempic and Wegovy in -- how we should think about that into the last quarter of the year and '25. Clearly, we've seen Wegovy with stocking in IO this quarter. But how do you see sales developing for that?
請來一對。因此,首先,如果可能的話,對 Ozempic 和 Wegovy 在美國以外的供應情況進行更多的描述——我們應該如何考慮今年最後一個季度和 25 年的情況。顯然,我們本季已經看到 Wegovy 在 IO 上備貨。但您如何看待這方面的銷售發展?
And also, Ozempic, it seems your supply constraints still when we can expect that those supply constraints to ease? And then maybe one on amylin monotherapy starting the Phase III -- phase I trial, getting ahead of myself there. How do you see the utility of this product relative to, say, CagriSema? And how have you changed the amylin relative to cagrilintide on its own?
另外,Ozempic,當我們可以預期這些供應限制會有所緩解時,您的供應限制似乎仍然存在?然後也許是胰淀素單一療法開始第三階段-第一階段試驗,在那裡超越了自己。您如何看待該產品相對於 CagriSema 等產品的實用性?您如何單獨改變胰淀素相對於卡格里林肽的作用?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Richard. Firstly, to Karsten on Supply and IO and afterwards, we turn to Martin for amylin.
謝謝你,理查。首先請Karsten 介紹Supply 和IO,然後請Martin 介紹胰淀素。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes. Thanks for that question, Richard. And the starting point is when you look at our performance in the first nine months, we grew 24%. And our guidance for the full year entails a midpoint of 25%. So as a consequence, then you should expect an acceleration going into the fourth quarter in terms of growth rates as well as absolute sales.
是的。謝謝你提出這個問題,理查德。首先,當你看看我們前 9 個月的表現時,我們成長了 24%。我們對全年的指導值為 25% 的中點。因此,您應該預期第四季度成長率和絕對銷售額都會加速。
And that acceleration will be driven by both units and what we've seen in the third quarter in IO with a very significant step-up for Wegovy sales. It's pretty much a doubling compared to Q2, albeit with some tailwind from inventory movements, which are associated with launches.
這種加速將由這兩個部門以及我們在第三季度看到的 IO 推動,Wegovy 銷售額大幅成長。儘管與發布相關的庫存變動帶來了一些推動力,但與第二季相比幾乎翻了一番。
Then a nice acceleration in IO in the third quarter, now growing at 22% in the quarter and to get to Q4, even further acceleration into the fourth quarter. As to supply between Ozempic and Wegovy, then yes, you are correct.
然後,第三季度 IO 出現了良好的加速,現在該季度增長了 22%,到第四季度,甚至在第四季度進一步加速。至於 Ozempic 和 Wegovy 之間的供應,那麼是的,你是對的。
So far, IO has been constrained on Ozempic. On the other hand, you see 60%-plus sales growth for (inaudible) in IO. So that's kind of the portfolio play we're pursuing in that geography. And then with now more than 15 Wegovy launches in IO, the momentum we are building there is, of course, rather substantial.
到目前為止,IO 一直受到 Ozempic 的限制。另一方面,您會看到 IO 領域(聽不清楚)的銷售額成長了 60% 以上。這就是我們在該地區追求的投資組合策略。現在,隨著 IO 領域推出超過 15 個 Wegovy,我們在那裡建立的勢頭當然是相當強勁的。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Karsten. And over to you, Martin, on amylin mono.
謝謝你,卡斯滕。馬丁,現在就交給你,單胰澱粉樣蛋白。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Yes. Thank you very much. As you know, we have a strategy that says that we address both diabetes, but specifically obesity with a holistic approach, building the broadest possible pipeline to cater to individual patient needs. These are complex diseases. And it's very, very clear also if you take the analogy from GLP-1, you can always address the same biology with slightly different modalities.
是的。非常感謝。如您所知,我們的策略是透過整體方法解決糖尿病問題,特別是肥胖問題,建立盡可能廣泛的管道來滿足個別患者的需求。這些都是複雜的疾病。而且非常非常清楚的是,如果您採用 GLP-1 的類比,您始終可以用略有不同的方式來解決相同的生物學問題。
Our own analogy is moving from liraglutide to semaglutide changing the pharmacokinetics and thereby also the pharmacodynamics in a beneficial way. The MLL biology is at least at the receptor level, even more complex than GLP-1. And therefore, to build a broader pipeline of different generations of Amlin assets is prudent. I think it's too early to speculate before we've seen any clinical data where and how we would see that being positioned.
我們自己的類比是從利拉魯肽轉向索馬魯肽,從而以有益的方式改變藥物動力學,從而改變藥效學。 MLL生物學至少在受體層面上,甚至比GLP-1更複雜。因此,建立更廣泛的不同世代 Amlin 資產的管道是謹慎的。我認為在我們看到任何臨床數據之前推測我們將在哪裡以及如何定位它還為時過早。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Martin, and also thank you for the questions. Then we are ready for the next set of questions, please.
謝謝你,馬丁,也謝謝你提出的問題。然後我們準備好回答下一組問題。
Operator
Operator
Florent Cespedes, Bernstein.
佛羅倫特·塞斯佩德斯、伯恩斯坦。
Florent Cespedes - Analyst
Florent Cespedes - Analyst
Two quick ones. First for Martin on CagriSema. I know that everybody is focused on weight loss. But Martin, could you share with us what kind of tolerance profile you're looking for this product as based on sales data from diabetes patients.
兩個快的。馬丁在 CagriSema 上首次亮相。我知道大家都在關注減肥。但是馬丁,您能否根據糖尿病患者的銷售數據與我們分享您正在尋找該產品的耐受性概況。
We see that there is increased efficacy on weight loss, but also in this level of nausea or gastrointestinal adverse event with the combination of CagriSema versus the individual component. So could you share with us what kind of level of side effects had effects you're all looking for? Will it be the same vein as mantra or higher?
我們發現,與單獨的成分相比,CagriSema 的組合不僅可以提高減肥效果,而且可以減少噁心或胃腸道不良事件的發生。那麼您能否與我們分享您所尋求的副作用達到什麼程度呢?它會與咒語同脈或更高級嗎?
And my second question, very quick. Maybe could you share with us when you believe that you could provide a new midterm guidance for the group?
我的第二個問題,很快。當您相信自己可以為集團提供新的中期指導時,您可以與我們分享嗎?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you for those two questions. Firstly, on Martin, if you could reiterate your previous tolerability commentary on CagriSema?
謝謝你提出這兩個問題。首先,關於 Martin,您能否重申您先前對 CagriSema 的耐受性評論?
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Yes. Thank you very much for that question. As we just discussed, these are still early days. We are still basing all of our assumptions on data derived from Phases I and II. Based on what we know and based on how we understand the biology, as you said yourself, we expect to see really unsurpassed weight loss.
是的。非常感謝你提出這個問題。正如我們剛才討論的,現在還處於早期階段。我們的所有假設仍然基於第一階段和第二階段的數據。根據我們所知道的以及我們對生物學的理解,正如您自己所說,我們期望看到真正無與倫比的減肥效果。
At this point in time, we expect to see good glycemic control in type 2 diabetes together with a strong weight loss. And based on what we've seen so far, that will come with a safety and tolerability profile broadly in line with what we see with GLP-1 treatment.
目前,我們預期第 2 型糖尿病患者的血糖將得到良好控制,同時體重也會大幅下降。根據我們迄今為止所看到的情況,其安全性和耐受性與我們所看到的 GLP-1 治療大致一致。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Martin. And over to you, Karsten, the midterm direction?
謝謝你,馬丁。卡斯滕,中期方向是什麼?
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes. Midterm guidance, Florent. Then right now, we're rolling on our strategic aspirations 2025. So you shouldn't expect us to issue any new midterm guidance until we're done executing on that plan. So late '25, beginning of '26 would be a fair expectation.
是的。中期指導,弗洛倫特。那麼現在,我們正在努力實現 2025 年的策略願景。所以 25 年末、26 年初是一個合理的預期。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Karsten, and thank you, Florent. Then we are ready for the next set of questions, please.
謝謝你,卡斯滕,謝謝你,弗洛倫特。然後我們準備好回答下一組問題。
Operator
Operator
Martin Parkhoi, SEB.
馬丁·帕克霍伊,SEB。
Martin Parkhoi - Analyst
Martin Parkhoi - Analyst
Yes, Martin, SEB. This was not a plant question, but this is Karsten. Since the stock is down 5% since you're on the call commented on your potential mathematical growth in 2025. I would like to know, was this a planned attempt by you to talk down consensus to forecast? Or was this just an improved hypothetically mathematically way to get something on the supplier next year?
是的,馬丁,SEB。這不是植物問題,但這是卡斯滕。自從您在電話會議上評論了 2025 年潛在的數學增長以來,該股已下跌 5%。或者這只是一種改進的假設數學方法,可以在明年從供應商那裡獲得一些東西?
And then second question. This is for Martin. Just on the recent agreement with Accentis on once monthly preparations. You can see from Accentis that the lead candidate in this agreement is on semaglutide. How fast can you actually bring on once monthly semaglutide to the market?
然後是第二個問題。這是給馬丁的。就在最近與 Accentis 達成的每月一次準備工作協議。從 Accentis 中可以看出,該協議的主要候選藥物是索馬魯肽。您能以多快的速度將每月一次的索馬魯肽推向市場?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Martin. Firstly, on previous commentary for you, Karsten, related to 2025, and then we'll hand it over to Martin afterwards.
謝謝你,馬丁。首先,Karsten,先前為您發表的有關2025年的評論,然後我們將其交給Martin。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes. Thanks for that question, Martin. So I'm not trying to manipulate the consensus numbers. So my comment was, first of all, just to say that we issue guidance in February, as we always do. We scale, as we've done in the last few years.
是的。謝謝你提出這個問題,馬丁。所以我並不是試圖操縱共識數字。因此,我首先想說的是,我們將像往常一樣在二月發布指導意見。正如我們過去幾年所做的那樣,我們不斷擴大規模。
And then just a reminder about the magnitude of growth in terms of absolute growth and a higher base and what that entails in terms of growth rates. I'm sure you can all calculate that, but there was no more than that.
然後提醒一下絕對成長和更高基數方面的成長幅度以及這在成長率方面意味著什麼。我相信你們都可以計算出來,但僅此而已。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Karsten. Very clear. And Martin on the once monthly technology and timelines for the lead candidate.
謝謝你,卡斯滕。非常清楚。馬丁則介紹了首席候選人每月一次的技術和時間表。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Yes. Thank you very much for that question. I have to say it's still early days. It's exciting, but it's still early days. And we're not even in first human dose, and this is a novel technology. So I cannot really speculate as to when we could have that specific opportunity on the market.
是的。非常感謝你提出這個問題。我不得不說現在還為時過早。這很令人興奮,但現在還處於早期階段。我們甚至還沒有進行第一劑人體劑量,這是一項新技術。因此,我無法真正推測我們何時可以在市場上擁有特定的機會。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Martin. And also thank you to you, Martin, for those two questions. Next set of questions, please.
謝謝你,馬丁。也要感謝馬丁提出這兩個問題。請提出下一組問題。
Operator
Operator
Kerry Holford, Berenberg.
凱莉·霍爾福德,貝倫貝格。
Kerry Holford - Analyst
Kerry Holford - Analyst
Just a couple of questions remaining for me please for Karsten. Can you quantify the rebate adjustments that you mentioned in the press release for Q3 specifically with regard to products, if you are willing to do that?
卡斯滕還有幾個問題想問我。如果您願意的話,您能否量化您在第三季新聞稿中提到的特別針對產品的回扣調整?
And then also Wegovy stocking mentioned in the US regions in Q3. Should we expect this to reverse in Q4? Or is this still -- should we expect stocking to continue to build from a year? It sounds like your commentary with regard to underlying IO growth still very positive. So just looking to understand the magnitude of that stocking and your expectations going forward?
然後也提到了第三季在美國地區的 Wegovy 備貨。我們是否應該預期這種情況會在第四季出現逆轉?或者這仍然是——我們是否應該預期庫存會繼續增加一年?聽起來您對潛在 IO 成長的評論仍然非常積極。那麼只是想了解該庫存的規模以及您對未來的期望嗎?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Kerry, over to you, Karsten, for one-offs in the quarter, US and IO.
謝謝你,Kerry,交給你了,Karsten,在本季美國和 IO 的一次性工作。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes. So as to gross to net adjustments in the quarter, it's largely neutral. So the quarter, you should see as slightly neutral in terms of gross to net adjustments. We do have negative adjustments on Victoza related to prior periods driven by higher exposure towards Medicaid in the US. And on the other hand, then we have some favorability mainly on Ozempic, but net-net, broadly neutral in the quarter.
是的。至於本季的毛淨調整,基本上是中性的。因此,本季的總調整與淨調整應略有中性。由於美國醫療補助曝險增加,我們確實對 Victoza 進行了與前期相關的負面調整。另一方面,我們主要對 Ozempic 有一些好感,但本季總體上是中性的。
And so the second question with regards to IO and Wegovy. This is just to call out that this was not end-user consumption, but that we have a stocking in connection with the launches we're pursuing in national operations.
第二個問題是關於 IO 和 Wegovy 的。這只是為了指出這不是最終用戶消費,而是我們有與我們在國家運營中追求的發布相關的庫存。
So we do not expect a major reversal of inventories into Q4. But of course, it's -- we cannot continue to build inventories in connection with launches unless they're new launches. So just noting that it's a one-off positive impact in the quarter. That's the way to think about it.
因此,我們預計第四季度庫存不會出現重大逆轉。但當然,我們不能繼續建立與發布相關的庫存,除非它們是新發布的。因此,請注意,這是本季一次性的正面影響。這就是思考的方式。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Perfect. Thank you, Karsten, and thank you, Kerry. Then we are ready for final set of questions, please.
完美的。謝謝你,卡斯滕,謝謝你,克里。接下來我們準備好回答最後一組問題。
Operator
Operator
Mattias Häggblom, Handelsbanken.
Mattias Häggblom,德國商業銀行。
Mattias Häggblom - Analyst
Mattias Häggblom - Analyst
I have two questions, please. So firstly, at the C&D earlier this year, Novo shared that grid is sourced externally through CDMO contracts. So in light of what appears to be a very likely commercial launch roughly a year from now. I wanted to ask if external the most sourcing of CAG remains the plan. And while producing CAGR in-house, it's not critical in light of the experience from semaglutide.
我有兩個問題,請問。首先,在今年稍早的 C&D 上,Novo 表示,電網是透過 CDMO 合約從外部採購的。因此,鑑於大約一年後很可能會進行商業發布。我想問一下,CAG 的大部分採購是否仍然是外部採購計劃。雖然內部產生複合年增長率,但鑑於索馬魯肽的經驗,這並不重要。
And then secondly, I wonder if you could remind me, assuming antitrust authorities, for whatever reasons, did decide to try and block the Catalant transaction, what flexibility do you have in that plan B to scale up capacity as quickly as possible, not least in light of constraints or expertise in setting up these sites?
其次,我想知道你是否可以提醒我,假設反壟斷機構出於某種原因確實決定嘗試阻止 Catalant 交易,那麼你在 B 計劃中擁有什麼靈活性來盡快擴大產能,尤其是考慮到建立這些網站的限製或專業知識?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Mattias. And both of those to you, Karsten firstly, on Cakesema supply chain and then on Catalent.
謝謝你,馬蒂亞斯。 Karsten,這兩個都是你的,首先是 Cakesema 供應鏈,然後是 Catalent。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes. Thank you for those questions, Mattias. It's correct that the CAG component we source externally, and that's basically based on a consideration around capabilities and manufacturing footprints. So it's rational choice. And of course, we take historic learnings with us in terms of ensuring that we have a resilient setup into the future for our external sourcing approaches, including cagri-semaglutide.
是的。謝謝你提出這些問題,馬蒂亞斯。我們從外部採購 CAG 組件是正確的,這基本上是基於對能力和製造足蹟的考慮。所以這是理性的選擇。當然,我們吸取了歷史教訓,確保我們為未來的外部採購方法(包括卡格里索馬魯肽)建立了彈性的設定。
Then secondly, on Catalent and the so-called Plan B, yes, that we do have, that's part of running business when you don't have hundreds of certainty. And this is really a question about continuing to scale the way we've been scaling in the past few years. So really driving more output from our internal supply chain as well as continue to contract the external capacity should we get into that situation.
其次,關於 Catalent 和所謂的 B 計劃,是的,我們確實有,這是當你沒有數百個確定性時經營業務的一部分。這實際上是一個關於繼續以過去幾年的方式擴展的問題。因此,如果我們遇到這種情況,確實會從我們的內部供應鏈中推動更多產出,並繼續收縮外部產能。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Karsten, and thank you to you, Mattias. And this concludes the Q&A session. Thank you for participating and feel free to contact Investor Relations regarding any follow-up questions you might have. Before we close the call, I would like to hand it over to you, Lars, for any final remarks.
謝謝你,卡斯滕,也謝謝你,馬蒂亞斯。問答環節到此結束。感謝您的參與,如有任何後續問題,請隨時聯繫投資者關係部門。在我們結束通話之前,拉斯,我想請您發表最後的意見。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yes. Thank you, Jacob. And once again, I would like to thank Doug for his exceptional leadership over quite some years of our US operations. And wish Dave more good luck as his successor.
是的。謝謝你,雅各。我要再次感謝道格多年來對我們美國業務的卓越領導。並祝戴夫作為他的繼任者好運。
As we've spoken about, Novo Nordisk is in a strong growth momentum, and that's driven by our GLP-1 products, both in diabetes and obesity. And I hope it's also clear to all of you that we are scaling significantly to train this attractive growth profile in the coming years. And we also have very exciting Phase III readouts later this year.
正如我們所說,諾和諾德正處於強勁的成長勢頭,這得益於我們在糖尿病和肥胖症方面的 GLP-1 產品。我希望大家也清楚,我們正在大幅擴展規模,以在未來幾年培養這種有吸引力的成長態勢。今年稍後我們還將發布非常令人興奮的第三階段數據。
So we look forward to sharing those data with you in the future and to have robust discussions around that. So with that, thank you again for your interest, and we hereby close the call. Thank you.
因此,我們期待將來與您分享這些數據,並圍繞這些數據進行深入的討論。因此,再次感謝您的關注,我們在此結束通話。謝謝。
Operator
Operator
This concludes today's conference call. Thank you for participating. You may now disconnect.
今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。